Clareo Health | Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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Lead
Bausch & Lomb Incorporated
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.
Participants must meet the following IOP requirements at Visit 3
mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye
IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.
You may not be if
Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.
Participants with a central corneal thickness greater than 600 μm in either eye.
Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
Participants who do not have an intact posterior capsule in either eye .
Participants with aphakia in either eye.
Participants with previous or active corneal disease in either eye.
Participants with current or a history of severe dry eye in either eye.
Participants with current or a history of optic disc hemorrhage in either eye.
Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.
Participants with current or a history of macular edema in either eye.
Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.
Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.
Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).
Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).
Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).
